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FDA 510(k)

Regulora

K-Number: K211463 · 2021-11-24

ApplicantMetame Health, Inc.
Decision Date2021-11-24
Product CodeQMY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Regulora is a medical device manufactured by Metame Health, Inc.. It received FDA 510(k) clearance on 2021-11-24 under approval number K211463. The device is classified under product code QMY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Regulora?

Regulora is a medical device that received FDA 510(k) clearance on 2021-11-24. It is manufactured by Metame Health, Inc.. The 510(k) number is K211463.

When was Regulora approved by the FDA?

Regulora received FDA 510(k) clearance on 2021-11-24, under approval number K211463.

What company makes Regulora?

Regulora is manufactured by Metame Health, Inc..

What is the FDA product code for Regulora?

The FDA product code for Regulora is QMY.

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Official Source

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